Preventive effects of ulinastatin on post-endoscopic retrograde cholangiopancreatography pancreatitis in high-risk patients: a prospective, randomized, placebo-controlled trial.
OBJECTIVE
Previous studies have shown that ulinastatin may be effective at preventing pancreatitis after endoscopic retrograde cholangiopancreatography (ERCP). However, routine administration of ulinastatin is unlikely to be cost-effective. So the aim of this prospective study was to evaluate the effectiveness of low-dose ulinastatin at preventing pancreatitis in patients at high risk of post-ERCP pancreatitis.


METHODS
A total of 227 patients (mean age, 63 years; 54% men) were randomized to receive placebo (n = 108) or active drug (n = 119) immediately after ERCP and received active drug (100,000 U of ulinastatin) or placebo. Occurrence of post-ERCP pancreatitis and hyperamylasemia were compared between the 2 groups.


RESULTS
The overall incidence of pancreatitis was 6.2%, and no significant differences were observed between placebo- and ulinastatin-treated patients in terms of the frequencies of pancreatitis (5.6% vs 6.7%), abdominal pain, or hyperamylasemia. Pancreatic duct acinarization, papillectomy of ampulla of Vater adenoma, difficult cannulation, and female sex were identified as risk factors for pancreatitis in univariate analysis.


CONCLUSIONS
Low-dose prophylactic treatment with ulinastatin immediately after ERCP did not show a beneficial influence on the incidence of post-ERCP pancreatitis and hyperamylasemia in high-risk patients.
Yoo
Ji Won
JW
Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea.
Ryu
Ji Kon
JK
Lee
Sang Hyub
SH
Woo
Sang Myung
SM
Park
Joo Kyung
JK
Yoon
Won Jae
WJ
Lee
Jun Kyu
JK
Lee
Kwang Hyuck
KH
Hwang
Jin-Hyeok
JH
Kim
Yong-Tae
YT
Yoon
Yong Bum
YB
D015746:Abdominal Pain / Q000209:etiology / Q000517:prevention & control; D000368:Aged; D002760:Cholangiopancreatography, Endoscopic Retrograde / Q000009:adverse effects*; D004311:Double-Blind Method; D005260:Female; D006023:Glycoproteins / Q000008:administration & dosage*; D006801:Humans; D034321:Hyperamylasemia / Q000209:etiology / Q000517:prevention & control; D007723:Korea; D008297:Male; D008875:Middle Aged; D010195:Pancreatitis / Q000209:etiology / Q000517:prevention & control*; D011292:Premedication; D011446:Prospective Studies; D018570:Risk Assessment; D012307:Risk Factors; D017211:Treatment Failure; D014361:Trypsin Inhibitors / Q000008:administration & dosage*
D006023:Glycoproteins; D014361:Trypsin Inhibitors; C028665:urinastatin